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Clinical Strategy & Human Device Testing

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Sunnybrook Health Sciences Centre

2075 Bayview Avenue

Odette Cancer Centre, Jenkin Auditorium TB21

Toronto, ON M4N 3M5

Canada

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Event description
Human device testing is at the pinnacle of the medtech innovation process. Join us and learn how to establish a winning clinical strategy!

About this Event

Goldy Singh, VP Regulatory Affairs & Product Management, Profound Medical Inc. will walk the attendees through the exhilarating commercialization journey of the TULSA-PRO®, a novel technology which combines real-time MRI, robotically-driven transurethral ultrasound and closed-loop thermal feedback control, and is designed to provide customizable and predictable ablation of a surgeon defined region of prostate while actively protecting the urethra and rectum to help preserve the patient’s natural functional abilities.

Through this case study, Goldy will share key insights and lessons with the following key learning objectives:

  • Recognize the primary goals of a clinical strategy.
  • Understand the importance of establishing an overarching clinical strategy for early non-clinical, pre-clinical, and human clinical studies.
  • Appreciate the different types of clinical studies and how their designs relate to the overall goals of clinical testing (including regulatory, reimbursement, and marketing considerations).
  • Learn the process involved in planning and initiating a human clinical trial, including the different participants and their functions.
  • Understand tactical considerations for developing safe, cost-effective, and statistically robust clinical trials.

Schedule:

5:00-6:00pm: Presentation

6:00-6:30: Networking mixer (Light refreshments will be served)

N.B. A live webcast will be available for this lecture. More details will be available soon.

Guest Speaker: Goldy Singh, VP Regulatory Affairs & Product Management, Profound Medical Inc.

Goldy Singh is a senior member of Profound Medical management team. She joined Profound Medical Inc. in December 2011 as a VP Quality Assurance and Regulatory Affairs. In this role, she was responsible to establish compliant processes and provide strategic direction to commercialize a novel technology in Europe, Canada and the US. Her responsibilities extended in November 2016 to lead overall clinical research operations. She successfully concluded clinical trials, which enabled regulatory approvals of the novel technology. In April 2019, she accepted a new role, VP Regulatory Affairs and Product Management. In this role she is leading business strategy of a new product line. She works closely with internal and external stakeholders such as researchers, engineers, clinicians, hospital administrations, regulatory bodies etc. to ensure that the strategies are executable to achieve business results.

Before joining Profound Medical, Ms. Singh worked for Natus Medical, as Director Regulatory Affairs & Quality Assurance, managed compliance and day-to-day operations through a substantial growth period including six acquisitions and commercialization of high-tech medical devices. She also worked for Philips Medical Systems and C.R. Bard.

Goldy has a bachelor’s degree with major in biology and physics from Ranchi University, India.

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Date and Time

Location

Sunnybrook Health Sciences Centre

2075 Bayview Avenue

Odette Cancer Centre, Jenkin Auditorium TB21

Toronto, ON M4N 3M5

Canada

View Map

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